UPDATE 3-Japan's Takeda engaged in antitrust scheme to delay generic constipation drug, US jury finds

A U.S. jury on Monday found Japan-based Takeda Pharmaceutical liable for causing about $885 million in damages by delaying a generic version of its constipation drug Amitiza through an anticompetitive scheme. Jurors in federal court in Boston sided ‌with pharmacies, insurers, health funds and retailers including CVS and Walgreens, who said the delay forced them to overpay for the drug. The award could rise to several billion dollars, as U.S. antitrust law allows damages to be tripled.

The lawsuits, filed in 2021, are among a wave of cases targeting so-called "pay-for-delay" deals, in which brand-name drugmakers pay generic rivals to postpone launching cheaper versions of ‌medicines in exchange for resolving patent lawsuits. The U.S. Supreme Court ruled in 2013 such agreements can violate antitrust law. Takeda denied wrongdoing during the trial and said in ‌a statement it will "vigorously pursue" an appeal. Its attorneys declined to comment outside the courtroom.

The company said it was currently assessing the amount of the provision it must recognise in relation to the litigation and will revise its financial statements for the previous fiscal year that ended in March. "Takeda does not expect its FY2026 financial forecast or Management Guidance to be materially impacted, except for the adjusted free cash flow forecast" depending on the ⁠amount and timing of ​payment, if any, it added.

Takeda shares rose ⁠0.6% on Tuesday morning, while the benchmark Nikkei 225 was down 0.3%. FIRST TRIAL WIN FOR PLAINTIFFS Monday's verdict is the first time a jury has found a pharmaceutical company liable in class-action litigation over such pay-for-delay agreements. ⁠Three earlier trials ended in defense verdicts. "We were incredibly fortunate to have a committed jury that really showed up every day, took their job seriously," said Kristen Johnson, a lawyer for drug purchasers pursuing class-action ​claims against Takeda. "They understood that paying off a competitor has real consequences on competition." The case centered on Amitiza, a medication developed by Sucampo Pharmaceuticals, which partnered with ⁠Takeda to market the drug in the United States after its approval in 2006.

In 2012, Par Pharmaceutical sought FDA approval to bring a generic version of Amitiza to market. Sucampo and Takeda sued for patent infringement, while ⁠Par ​argued that the patents were invalid. The companies settled in 2014, with Par agreeing to delay launching its generic until January 2021, when it was allowed to sell an authorized version of Amitiza, known as lubiprostone, supplied by Sucampo under a profit-sharing deal. 'PAYOFF' Lawyers for the plaintiffs said the settlement amounted to a $210 million "payoff" that delayed generic competition by six years ⁠while giving Par a lucrative partnership. Sucampo was later acquired by Mallinckrodt in 2018. But Joshua Barlow, one of Takeda's lawyers, told jurors in his closing argument on Thursday the ⁠settlement had been lawful and pro-competition, saying that ⁠without it, generic Amitiza would still not be available because final patents run until October 2027.

"It increased competition," he said. The jury awarded $474.9 million to direct purchasers such as pharmacies and wholesalers, and $63.2 million to insurers and other "end payors." It also awarded damages to five retailers that ‌sued individually, including $191 million to ‌CVS and $121 million to Walgreens.

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